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510(k) Data Aggregation
K Number
K120508Device Name
CLEARLUMEN THROMBECTOMY SYSTEM
Manufacturer
WALK VASCULAR LLC
Date Cleared
2012-11-07
(260 days)
Product Code
QEZ, DXE
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
WALK VASCULAR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearLumen Thrombectomy System is intended to break-up, remove/aspirate soft emboli and thrombus from the peripheral vasculature.
Device Description
The ClearLumen Thrombectomy Device consists of a thrombectomy catheter, saline drive unit ("SDU") and waste collection bottles. The thrombectomy catheter is a multi-lumen 6F or 7F guide compatible, 135 cm in length and is used over the wire. The catheters have a 7 cm rapid exchange length. The device is intended for use with conventional 0.014″ guidewires. The proximal end of the catheter contains a polycarbonate hub that connects to the SDU and provides access to the infusion and aspiration lumens. The distal end of the catheter shaft is comprised of an atraumatic tip. The ClearLumen Catheter is connected to the battery operated SDU which allows for simultaneous lysing and aspiration of thrombus from the treatment site. The SDU contains a port for connection to a standard saline bag. The device uses a toggle switch to turn the pump on and off.
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